Duloxetine Delayed-Release Capsules recall
FDA recall D-0580-2025 · initiated Jul 25, 2025
Breckenridge Pharmaceutical, Inc. recalled Duloxetine Delayed-Release Capsules in Jul 2025 — an FDA Class II recall (D-0580-2025) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,856 bottles
Details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
- Recalling company
- Breckenridge
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- NJ, AZ, IN
- Initiated
- Jul 25, 2025
- FDA report date
- Aug 20, 2025
Frequently asked
- Was Duloxetine Delayed-Release Capsules recalled?
- Breckenridge Pharmaceutical, Inc. recalled Duloxetine Delayed-Release Capsules in Jul 2025 — an FDA Class II recall (D-0580-2025) because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine Delayed-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0580-2025 was: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Is a recalled Duloxetine Delayed-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Duloxetine Delayed-Release Capsules are affected?
- Distributed: NJ, AZ, IN. The recall covers these lots — Lot 240539C, Exp 1/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0580-2025.